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510(k) K022594

PLAYTEX BREAST PUMP by Playtex Products, Inc. — Product Code HGX

K022594 is an FDA 510(k) premarket notification submitted by Playtex Products, Inc. for the device "PLAYTEX BREAST PUMP". The FDA issued a decision of Substantially Equivalent on Nov 1, 2002. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Playtex Products, Inc. has 16 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 1, 2002
Date Received
Aug 5, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Pump, Breast, Powered
Device Class
Class II
Regulation Number
884.5160
Review Panel
OB
Submission Type
510(k)

Other clearances by Playtex Products, Inc.

  • K073662 — PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS (Jan 17, 2008)
  • K072376 — PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS (Dec 12, 2007)
  • K070745 — MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK… (Apr 13, 2007)
  • K061013 — PLAYTEX EMBRACE PETITE BREAST PUMP (Aug 15, 2006)
  • K060981 — PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS (May 9, 2006)
  • K032636 — PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV… (Nov 14, 2003)
  • K022882 — MODIFICATION TO PLAYTEX TAMPONS #24002 (Sep 16, 2002)
  • K020200 — PLAYTEX DEODORANT TAMPONS, MODEL 34802 (Mar 13, 2002)
  • K020201 — PLAYTEX DEODORANT TAMPONS, MODEL 34902 (Mar 12, 2002)
  • K020202 — PLAYTEX DEODORANT TAMPONS, MODEL 34702 (Mar 12, 2002)

Other clearances for product code HGX

  • K261782 — MODO DUO Electric Pump (B11621, B11673) (Oct 16, 2026)
  • K254203 — Wearable Breast Pump (Model S36) (Sep 17, 2026)
  • K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model… (Sep 3, 2026)
  • K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF) (Sep 1, 2026)
  • K260643 — Cimilre Dual Max (Aug 21, 2026)
  • K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) (Aug 20, 2026)
  • K260259 — DiscreetDuo™ Flow Wearable Breast Pump (Model S3) (Jul 24, 2026)
  • K261199 — Wearable Breast Pump (Model S32A) (Jul 13, 2026)
  • K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (Jun 26, 2026)
  • K261025 — Wearable breast pump (QY-101, QY-102, QY-108) (Jun 25, 2026)

FDA data resources

Source: FDA 510(k) database entry for K022594. Report a data issue: hello@regdatalab.com.